Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial.
Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial.
复制标题
青少年偏头痛患者药物依从性的多模式评估：CHAMP 试验的辅助研究。
DOI：
10.1093/jpepsy/jsab123
复制
发表时间：
2022
影响因子：
3.6
通讯作者：
CHAMPInves
中科院分区：
文献类型：
--
作者：
Reidy,BrookeL;Powers,ScottW;Coffey,ChristopherS;Chamberlin,LeighA;Ecklund,DixieJ;Klingner,ElizabethA;Yankey,JonW;Korbee,LeslieL;Porter,LindaL;Peugh,James;Kabbouche,MarielleA;Kacperski,Joanne;Hershey,AndrewD;CHAMPInves
目的调查青年偏头痛患者预防性用药依从性。方法采用328名CHAMP研究参与者(8-17岁)的数据，将依从性(自评、服药次数和血清药物水平)作为辅助研究进行评估。CHAMP是一项预防性药物的多点试验。参与者在为期六个月的积极治疗期间完成了预期的头痛日记，在此期间，年轻人每天服用两次阿米替林、托吡酯或安慰剂药片。通过每日日记收集自我报告的服药依从性。在每月的研究访问中，记录药片计数措施。在试验第3个月(试验中点)和第6个月(积极试验结束)，获取血清药物水平。在每个月的研究访问中，以及参与者在试验中期抽血的前几天，计算积极试验期间的自我报告和服药依从性百分比。计算非零血药浓度百分比以评估血药浓度数据。依从性测量是在几个社会人口统计因素的背景下进行比较和评估的。多元回归分析研究了服药依从性作为头痛结果的预测因素。结果自我报告和服药依从率很高(超过90%)，并在试验过程中持续。血清药物依从率略低，在整个试验期间显著下降(从84%降至76%)[t(198)=3.23，p=.001]。试验结束时依从性测量不能预测头痛天数；试验中点血清药物水平预测头痛相关功能障碍。结论青年偏头痛患者在临床试验过程中可以表现出并维持相对较高的药物依从性水平。
ObjectiveExamine preventive medication adherence among youth with migraine.MethodsAdherence (self-report, pill count, and blood serum drug levels) was assessed as an ancillary study that utilized data from 328 CHAMP Study participants (ages 8–17). CHAMP was a multisite trial of preventive medications. Participants completed a prospective headache diary during a six-month active treatment period during which youth took amitriptyline, topiramate, or placebo pill twice daily. Self-reported medication adherence was collected via daily diary. At monthly study visits, pill count measures were captured. At trial month 3 (trial midpoint) and 6 (end of active trial), blood serum drug levels were obtained. Self-report and pill count adherence percentages were calculated for the active trial period, at each monthly study visit, and in the days prior to participants’ mid-trial blood draw. Percentages of nonzero drug levels were calculated to assess blood serum drug level data. Adherence measures were compared and assessed in context of several sociodemographic factors. Multiple regression analyses investigated medication adherence as a predictor of headache outcomes.ResultsSelf-report and pill count adherence rates were high (over 90%) and sustained over the course of the trial period. Serum drug level adherence rates were somewhat lower and decreased significantly (from 84% to 76%) across the trial period [t(198) = 3.23,p= .001]. Adherence measures did not predict headache days at trial end; trial midpoint serum drug levels predicted headache-related disability.ConclusionsYouth with migraine can demonstrate and sustain relatively high levels of medication adherence over the course of a clinical trial.